DEPUY SYNTHES POWER TOOLS 3MM FLTD MATCHSTK,EXT 8.9MM,LESS AGGRESS; DRILLS, BURRS, TREPHINES AND ACCESSORIES (SIMPLE, POWERED)
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Catalog Number S-8NS-M |
Device Problem
Difficult To Position (1467)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/21/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported from (b)(6) that during a craniotomy surgical procedure, it was observed that the cutter device would not fit into the attachment device.There were no delays to the surgical procedure as a spare device was available for use.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Manufacturer Narrative
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(b)(4).The device manufacture date was documented as unknown in the initial report.It has been updated as oct 6, 2015.The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device passed all operational specifications.Therefore, the reported condition was not confirmed.An assignable root cause was not determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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